babies r us infants pain relief

Toys"R"Us, Inc.

Toys "R" Us, Inc Infants' Pain Relief Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 0.8 mL)
• Purpose
• babies r us infants pain relief Uses
• Warnings
  • Do not use
  • Ask a doctor before use if your child has
  • Ask a doctor or pharmacist before use if your child is
  • Stop use and ask a doctor if
  • Keep out of reach of children.
• Directions
• babies r us infants pain relief Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each 0.8 mL)

Acetaminophen 80 mg

Purpose

Fever reducer/pain reliever

babies r us infants pain relief Uses

temporarily:

• reduces fever
• relieves minor aches and pains due to:
• the common cold
• flu
• headache
• sore throat
• toothache

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if your child has

liver disease

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin

Stop use and ask a doctor if

• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

• do not give more than directed (see Liver warning)
• shake well before using
• find right dose on chart. If possible, use weight to dose; otherwise use age.
• use only enclosed dropper designed for use with this product. Do not use any other dosing device.
• fill to dose level
• dispense liquid slowly into child’s mouth, toward inner cheek
• if needed, repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• do not give for more than 5 days unless directed by a doctor
• replace dropper tightly to maintain child resistance
• this product does not contain directions or complete warnings for adult use

Attention: use only enclosed dropper specifically designed for use with this product. Do not use any other dosing device.

Other information

• store at 20°-25°C (68°-77°F)
• do not use if printed bottle wrap is broken or missing

Inactive ingredients

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

Questions or comments?

1-800-719-9260

Principal Display Panel

Infants’ Pain Relief

Acetaminophen

Concentrated Drops

Fever Reducer – Pain Reliever

Aspirin Free

Ibuprofen Free

Alcohol Free

Cherry Flavor

Use only with enclosed dropper

See New Warnings Information

Compare to the active ingredient of Concentrated Tylenol® Infants’ Drops

80 mg per 0.8 mL